Clinical Evaluation of White Spot Lesions Treated by S-PRG and ICON

September 22, 2022 updated by: Mohamed Wakwak, Al-Azhar University

Clinical Evaluation of White Spot Lesions Treated by S-PRG Coating Material and Resin Sealants in Comparison With Resin Infiltration by Using Spectrophotometer and Laser Fluorescence. (A Randomized Controlled Trial) (WSLs)

Randomized with (1:1) prospective, double-blind, controlled trial. Subjects will be randomized to receive S-PRG and the control group receives ICON.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Interventions: - All the procedures will be performed by the same clinician. DIAGNOdent will be used to assess the fluorescence loss of WSLs and the adjacent sound enamel. WSLs in permanent teeth will be treated according to the manufacturer's instructions with:

  • Group I (Control group): 20 teeth will be treated with ICON.
  • Group II ( EXPERIMENTAL) : 20 teeth will be treated with PRG BarrierCoat.

Observation: - The treatment methods will be assessed immediately after the intervention, 3 months,6 months, and one year. The data will be collected for evaluation of the difference in color and fluorescence loss between the treatment groups, by using DIAGNOdent devices, over different time intervals.

Ethical considerations: The research protocol is approved by the ethical committee, Faculty of Dental Medicine, Al-Azhar University and the enrolled patients should sign a written consent form.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11768
        • Mohamed Wakwak

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients within 20-40 years of age.
  • Each patient has 4 or more WSLs.
  • Mild and moderate WSLs according to Gorelick's scale.
  • Good oral hygiene and willing patients who can attend the study visits.
  • a Symmetrical number of permanent teeth in each arch (mesial to second molars).

Exclusion Criteria:

  • Active carious lesions.
  • Facial surface restorations.
  • Intrinsic and extrinsic stains.
  • Patients who have a significant medical history or if they smoke.
  • Criteria for discontinuation; Mortality and acquiring severe debilitating disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Icon resin infiltration material
Smooth surface resin infiltration comprises three steps for resin infiltration; Icon etch, Icon dry, and Icon infiltrant
Other: Giomer
fluoride-releasing coating material containing surface reaction-type pre-reacted glass-ionomer (S-PRG) fillers
Other Names:
  • PRG Barrier Coat
Other: Two composite resin sealants
Unfilled composite resin sealants
Other Names:
  • Permaseal and Optiguard
Experimental: PRG Barrier Coat
fluoride-releasing coating material containing surface reaction-type pre-reacted glass-ionomer (S-PRG) fillers
Other: Two composite resin sealants
Unfilled composite resin sealants
Other Names:
  • Permaseal and Optiguard
Experimental: Permaseal composite resin sealant
Permaseal unfilled composite resin sealants
Other: Giomer
fluoride-releasing coating material containing surface reaction-type pre-reacted glass-ionomer (S-PRG) fillers
Other Names:
  • PRG Barrier Coat
Experimental: Optiguard
Optiguard unfilled composite resin sealant
Other: Giomer
fluoride-releasing coating material containing surface reaction-type pre-reacted glass-ionomer (S-PRG) fillers
Other Names:
  • PRG Barrier Coat

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patients tooth color change
Time Frame: 1 year
Color change with Vita Easyshade When the Delta E increased, it consider esthetic improving
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patients tooth caries lesion state
Time Frame: 1 year
Laser fluorescence score Assessing of carious lesions state of the lesions by Diagnodent Minimum score is 0, while maximum score is 20 When score is decreased it consider positive results
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Investigators

  • Study Director: Khalid Noman, PROF, Alazhar Univerisity

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2021

Primary Completion (Actual)

August 30, 2022

Study Completion (Anticipated)

October 11, 2022

Study Registration Dates

First Submitted

September 19, 2022

First Submitted That Met QC Criteria

September 21, 2022

First Posted (Actual)

September 22, 2022

Study Record Updates

Last Update Posted (Actual)

September 26, 2022

Last Update Submitted That Met QC Criteria

September 22, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2286488

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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